Monitoring device

ABSTRACT

A monitoring device suitable for attachment to a surface of a subject, the device having a data collector and a processor. The data collector includes a flexible foil attached to a less flexible socket, where the foil forms a dermal side surface of the data collector for adhesion to a skin surface of a subject to be monitored. To enable communication of electrical signals between the data collector and the processor, the data collector includes a distribution structure formed as a pattern of an electrically conductive material on an outer surface of a foldable sheet. The foldable sheet forms a layer in the flexible foil and having an interface portion which is folded into an aperture in the socket to form a coupling inside the cavity for electrical communication with a matching coupling of the processor when the processor is received in the cavity.

INTRODUCTION

Data logging and monitoring of physiological signals are widely used,e.g. for sports training and for medical purposes, e.g. for surveillanceof critical physiological parameters detectable e.g. from electricalsignals generated in the body, skin or blood color, temperature, lightabsorbance etc.

The present invention relates to a monitoring device for monitoring asubject. Particularly, the invention relates to a device comprising adata collector and a separate processor. The data collector is adaptedfor adhesive attachment to a body surface.

BACKGROUND OF THE INVENTION

One group of existing monitoring devices comprises a patch which isattachable to a skin surface and which includes a processor and/or atransmitter for transmitting a captured body signal in raw or processedform. Such monitoring devices are known e.g. for sport training purposeswhere they are integrated in a belt to be fastened over the chest, aboutthe wrist or at other body locations. Typically, they are usedrepeatedly by the same user.

Another group of existing devices comprises a patch working as a sensoror data collector and a separate processor which can process thecollected data. The patch and processor are typically joined adhesivelyor by a kind of snap-locking feature. Due to the two-part structure witha separate processor, the known devices often become bulky and heavy,and they are typically not comfortable to wear, or they are difficult tofit onto the body. As an example, it is not unusual that cloth, hair andother items become trapped between the data collector and the processor,that data exchange between the data collector and the processor fails,or that the data collector and processor separates unintentionally.

WO 2006094513 discloses a micro electronic system predominantly formonitoring physiological or neurological conditions. The system isembedded in a three-dimensional adhesive device which can be attached tothe skin of a mammal. The microelectronic system uses wirelesscommunication and it is useful for measuring ECG (Electro CardioGraphy),EMG (Electro MyoGraphy), EEG (Electro EncephaloGraphy), blood glucose,pulse, blood pressure, pH, and oxygen.

WO 03/065926 discloses a wearable biomonitor with a flexible and thinintegrated circuit. The disclosure includes ways to achieve high comfortof wear by using a thin layer adhesive or pads of adhesive for fixationto the skin.

U.S. Pat. No. 5,054,488 discloses an opto-electronic sensor forproducing electrical signals representative of a physiologicalcondition. The sensors may be attached to the body by a double-sidedpressure sensitive adhesive on a polyester lining.

SUMMARY OF THE INVENTION

It is an object of embodiments of the invention to provide a device witha two-part structure which, in spite of being in two parts, is easy touse, comfortable to wear, and which minimizes the risk of gettingentangled with items during use, and generally performs better than theknown devices.

According to a first aspect, the invention provides a monitoring devicecomprising a data collector and a separate processor, the data collectorcomprising a flexible foil attached to a less flexible socket, the foilforming a dermal side surface for adhesion of the data collector to askin surface of a subject to be monitored and the socket forming acavity for receiving the processor, wherein the data collector furthercomprises a foldable sheet with a first pattern of an electricallyconductive material on an outer surface thereof, the first patternextending between a sensing portion of the sheet which forms a layer inthe flexible foil and an interface portion of the sheet which is foldedinto an aperture in the socket and forms an electrical coupling forelectrically connecting the processor to the data collector.

The foldable sheet enables a very thin conductor facilitating electricalcommunication between the processor and the data collector. This enablesa very low height of the device over the skin surface of the subject.Due to the combination between the flexible foil in which the foldablesheet is integrated, and the more rigid structure of the socket, goodcommunication can be ensured even with a flexible foil and sheetstructure. Accordingly, the invention facilitates a solid device with alow height and good electrical connectivity. Since the foldable sheetforms a layer in the flexible foil, the foil itself becomes anelectrical conductor which saves material and thus both weight andheight, and which simultaneously can reduce the manufacturing costs.

Particularly, the folded sheet may be a continuous single sheet elementwhich is folded.

The main function of the data collector may e.g. be to adhere to thebody of the subject, to recognize physiologic signals there from, and totransmit the monitoring signals which represents the physiologic signalto the processor. The monitoring signal may be the physiologic signalitself or the data collector may comprise a transducer for converting aphysiological signal into another form, typically a form which is easierto transfer to the processor and/or a form which is more easilyprocessed by the processor. As it will be described in further detailsin a separate paragraph, the transducer may form part of the datacollector, the processor or both.

Examples of physiological signals relevant in connection with theinvention include (ECG), electromyography (EMG) electroencephalography(EEG), galvanic skin response (GSR), photoplethysmography (PPG),phonocardiogram (PCG), arterial oxygen saturation (Sp02), muscleactivity, emotions, arterial saturation of carbon monoxide (SpCO) andblood carbon dioxide (CO2), blood pressure (BP), respiration, such asrespiration frequency (RF) and/or respiration volume (RV), heart rate(HR), pulse, bioimpedance, and/or rhythm, heart sounds, respiratorysounds, blood pressure, posture, wake/sleep, orthopnea, heat flux,patient activity, snoring sound or other sounds of the subject, andtemperature, such as skin temperature (ST), and/or core bodytemperature.

Such signals may be significant for a physiological condition of thesubject and in particular for vital parameters where failure will leadto death.

The data collector includes the two main components, i.e. the foil andthe socket. The foil may be made from a flexible tape or patch with anadhesive on at least the dermal side surface.

Herein, the dermal side surface is, by definition, that surface of thedata collector which is for adhesive attachment to the skin surface ofthe monitored subject. Also by definition, the dermal side of the entiredevice or of individual structural entities in the device is that sideof the device or structural entity facing towards the skin surface whenthe device is attached to a subject.

The dermal side surface may comprise a pressure sensitive adhesive (PSA)for adhesive attachment of the device to the body. In one embodiment,the dermal side surface comprises a gel, e.g. a hydrogel with adhesiveproperties. The hydrogel may or may not be electrically conductive.Different forms or formulations of the hydrogel with differentproperties may be used within the same system or device.

Examples of suitable hydrogels may be obtained from AxelgaardManufacturing Co., Ltd: http://www.axelgaard.com/home.htm or itssubdivision AmGel Technologies; http://www.amgel.com/index.html.

The adhesive or gel may form a transmission passage for thephysiological signal from the subject on which the device is attached.

In particular, it may be an advantage to use an adhesive, e.g. in formof a hydrogel or similar material with properties ranging from soft andweak jelly-like ranging up to hard and tough yet deformable, and it mayfurther be an advantage to use a material with a refractive index in therange of 1.01-1.7 e.g. 1.30-1.45, such as 1.34-1.42. In this way, theindex becomes close to that of average skin whereby reflection of thephysiological signal, be that an acoustic or optic signal, can beprevented or at least reduced.

Herein, flexibility of the foil means that the foil can bend to acertain degree, i.e. it can follow the contour of the body. The foilmay, additionally, be lengthwise elastically deformable such that it canbe stretched, e.g. to follow stretching of body parts.

The foil, and particularly the foldable sheet could be made ofnon-conductive material. Herein, non-conductive should be understood ashaving an electrical conductivity much lower than that of the conductivepattern(s), e.g. having a resistivity twice that of the conductivepattern or 4 times that of the conductive pattern or more than 10 timesthat of the conductive pattern.

The socket is less flexible and it is rigidly connected to the foil,e.g. by a strong adhesive preventing the removal of the socket from thefoil. The socket may have a bottom following the surface of the foil,and sidewalls extending upwardly from the bottom and forming a flangeabout an opening in which the processor is received.

The sensing portion of the foldable sheet is integral with the foil,i.e. it forms one of the layers in the foil, and it is therefore held ina plane defined by the foil. Herein, the definition of the interfaceportion being “folded into an aperture in the socket” means that theinterface portion is bend, or turned over, or in any other way isdeformed out of the plane of the foil and into the cavity via an openingin the socket. The interface and sensing portions are therefore one andthe same sheet, and due to the foldability, this sheet may both beintegrated in the foil and it may extend into the cavity where it formsa coupling for electrical communication with the processor.

The first pattern is printed on the same surface, specified as “an outersurface” of the foldable sheet. Depending on the way the foldable sheetis located in the foil structure, the outer surface becomes in adirection towards the dermal side surface of the data collector or inthe opposite direction away from the dermal side surface. Depending onthe way the interface portion is folded into the aperture of the socket,the outer surface of the interface portion of the sheet faces away fromthe outer surface of the sensing portion, or it faces in the samedirection as the outer surface of the interface portion, i.e. the outersurface and thus the first pattern of the interface portion may facetowards the dermal side surface or opposite the dermal side surface,which is typically towards the processor.

The processor comprises a computer unit e.g. for processing aphysiological signal which is received from the individual.Additionally, the processor may comprise a battery, computer memory, adisplay and other features, e.g. for enabling communication withexternal devices, e.g. wireless communication features etc.

In some embodiments in the system according to the present invention thedevice comprises at least one sensor and optionally several differentsensors. The sensor(s) may be configured for measuring one or morephysiological signal selected from electrocardiography (ECG),electromyography (EMG) electroencephalography (EEG), galvanic skinresponse (GSR), phonocardiogram (PCG), arterial oxygen saturation(Sp02), muscle activity, emotions, arterial saturation of carbonmonoxide (SpCO) and blood carbon dioxide (CO2), blood pressure (BP),respiration, such as respiration frequency (RF) and/or respirationvolume (RV), heart rate (HR), pulse, bioimpedance, and/or rhythm, heartsounds, respiratory sounds, blood pressure, posture, wake/sleep,orthopnea, heat flux, patient activity, snoring sound or other sounds ofthe subject, and temperature, such as skin temperature (ST), and/or corebody temperature.

In general, the physiological signal will be recognized and picked upfrom the individual by a structure which in the following will bereferred to as “the detecting component”. This component can e.g.include electrodes (polar, bipolar), pressure sensors, needles withelectrodes, accelerometers, photo detectors, microphones, ion specificfield effect transistors (ISFET), a NTC (negative temperaturecoefficient) resistors, band gap detectors, ion membranes, enzymereactors or condensers etc. In particular, the device may comprisecomponents for non-invasive capturing of the physiological signal, e.g.electrodes or optic recognition means. The component could, however,also be for invasive capturing of the physiological signal, e.g. in theform of a needle for taking fluid samples, or a needle containing anelectrode for subcutaneous capturing of an electrical physiologicalsignal.

Accordingly, the data collector may further comprise at least oneelectrode for communicating an electrical signal between the monitoringdevice and the subject, e.g. for capturing an electrical activityproduced by the subject. The first pattern may be electrically connectedto the electrode and thereby provide individual conductivity betweeneach electrode and the coupling inside the cavity of the socket.

The at least one electrode may comprise a second pattern of electricallyconductive material on the outer surface of a sensing portion of thefoldable sheet. The second pattern and the first pattern could be ofidentical electrically conductive material.

Since both the second pattern and the first pattern are provided on theouter surface of the foldable sheet, i.e. on the same surface of thefoldable sheet, it becomes very easy to produce the data collector.

In summary, it can be produced by printing the first and second patternson one side of a foldable sheet, integrating a sensing portion of thesheet in a laminated foil structure, and bending an interface portion ofthe sheet through an aperture in the socket. The result is potentially avery flat, cheap, and reliable structure with a low weight and a highstrength, e.g. as a result of a laminated structure of the foil, and asa result of the rigid and less flexible structure of the socket. Due tothe foldability of the sheet which carries the first, and optionallyalso the second pattern, the quality of the connection between the sheetand the processor may suffer, i.e. the sheet may become deformed byfolding whereby the connectivity can be lost. This can be remedied byreceiving the interface portion of the foldable sheet in a plugstructure which is rigid and which can be received in a matching socketin the processor. This, however, may increase the thickness, weight, andcosts of the device. To provide a slim, cheap, and good electricalconnectivity, the interface portion of the foldable sheet may, itself,form the coupling in the cavity—i.e. the coupling may be constituted bythe interface portion. To increase the quality of the connection, it maybe desirable to arrange the socket, which is less flexible than thefoil, between the interface portion and the sensing portion of the sheetaccordingly, the processor can be pressed against the interface portionof the foldable sheet and the socket may form a rigid backing behind thefoldable sheet and thus ensure connectivity.

To further increase the good connectivity between the interface portionof the foldable sheet and the processor, the device may comprise aspring structure which presses the interface portion towards thecoupling of the processor.

Particularly, the spring structure may form an integrated part of thesocket, and may be located between the interface portion of the sheetand the dermal side surface of the data collector.

The aforementioned pressing of the interface portion towards theprocessor may be provided by an upwards spring force, i.e. a springforce in a direction from the coupling of the socket towards theprocessor′, perpendicular to and directed away from the dermal sidesurface.

The processor may particularly be receivable into the cavity in adownwards direction being perpendicularly to and directed towards thedermal side surface, i.e. opposite the aforementioned upwards direction.

Alternatively, the processor may be receivable into the cavity in asideways direction being parallel to and directed towards the dermalside surface.

To further increase the simplicity, to reduce the weight and costs, andto increase the durability of the device, the spring structure maycomprise a number of upwards protrusions separated from adjacentprotrusions by a recess or opening in the socket. Particularly, suchprotrusions may be formed in one part with the remaining parts of thesocket, i.e. it may be made from the same material, e.g. molded in onepiece. The protrusions may e.g. project in the aforementioned upwardsdirection relative to the bottom of the socket.

The recesses or openings between adjacent protrusions could be oblongand extend in a direction being parallel to the sideways direction. Thisfacilitates sliding of the processor in contact with the coupling, andthereby facilitates the sideways insertion of the processor into thecavity.

The socket may form a locking structure adapted to hold the processor inthe cavity. Particularly, the socket may form a locking structure forsnap-locking of the processor, i.e. automatically engaging the processorwhen the processor is inserted in the cavity. The locking structure maybe for releasable locking of the processor, and particularly, thelocking structure may be adapted for controlled destruction for removalof the processor. This ensures one-time use of the data collector,particularly, when the controlled destruction is such that renewedinsertion of the processor is prevented or at least such that theprocessor is no longer capable of being fixed in the cavity.

The locking structure may apply a constant force on the processor in adownwards direction being perpendicularly to and directed towards thedermal side surface thereby forcing the processor into the cavity. Thelocking structure thereby presses the processor against the force of theaforementioned springs, and a good electrical contact between the datacollector and the processor can be established.

In a second aspect, the invention provides a monitoring devicecomprising a data collector and a separate processor, the data collectorcomprising a flexible foil attached to a less flexible socket, the foilforming a dermal side surface for adhesion of the data collector to askin surface of a subject to be monitored and the socket forming acavity for receiving the processor, wherein the processor comprises aconnector for establishing a cabled connection to an external unit, theconnector being covered by the socket, when the processor is received inthe cavity.

According to this aspect of the invention, the socket prevents access tothe connector and the user is therefore prevented from establishingcabled connections to external units when the processor is in thesocket. Since the computer would typically be in the socket when thedevice is attached to the body of the user, the invention according tothe second aspect prevents cabled connection to the processor when thedevice is attached to the body of the user, and this reduces the risk ofmalfunctioning and the potential risk of causing electrical shock if aconnected external unit has a malfunction. Accordingly, the inventionaccording to the second aspect increases the safety in using a deviceaccording to the first aspect of the invention.

The connector could e.g. be a mini USB connector or any similar kind ofstandardized connector, e.g. for connection of the processor to anexternal computer, battery charger, or other external equipment.

In a third aspect, the invention provides monitoring device comprising adata collector and a separate processor, the data collector comprising aflexible foil attached to a less flexible socket, the foil forming adermal side surface for adhesion of the data collector to a skin surfaceof a subject to be monitored and the socket forming a cavity forreceiving the processor, wherein the processor and the socket havematching shapes facilitating the processor to be received in the cavityonly in one single orientation of the processor relative to the socket.

By “matching shape”, is herein considered the shape of the contour ofthat edge of the processor which is received in the cavity, and thecorresponding shape of that edge of the cavity in which the processor isreceived. For simplicity, this will be referred to herein as “theinterface”.

As an example, the interface should not be circular, oval, quadrangular,or isosceles triangular. In a more general definition, the shape shouldbe such that at most one line of symmetry, i.e. a line along which theshape of the interface becomes symmetric or mirrored across the line,can be established. If two or more of such lines of symmetry can beestablished for the interface, then the processor would be receivable inthe cavity in two or more different orientations depending on the numberof lines of symmetry. The purpose of the invention according to thethird aspect is to avoid such multiple possibilities of orientation andthereby ensure correct attachment of the processor in the socket. Theinvention according to the third aspect of the invention thereforeincreases the correctness of use and facilitates less faultyattachments.

The devices according to the second and third aspects of the inventionmay comprise any of the features mentioned relative to the deviceaccording to the first aspect of the invention.

In a fourth aspect, the invention provides a method of making a deviceaccording to the first aspect of the invention. The method comprises thesteps of:

-   -   providing an interface pattern of an electrically conductive        material on an outer surface of a foldable sheet;    -   providing a flexible foil which includes the foldable sheet and        which forms a dermal side surface for adhesive contact with a        skin surface;    -   providing a socket which is less flexible than the foil;    -   attaching the socket to an upper surface of the foil facing away        from the dermal side surface; and    -   folding an interface portion of the sheet through an aperture in        the socket; and    -   providing from the interface portion, a coupling for electrical        communication with a matching coupling of the processor.

In one embodiment, the steps are carried out in the order mentionedabove.

The method may comprise the step of providing a sensing pattern of theelectrically conductive material to the outer surface of a sensingportion of the sheet, and arranging the sensing portion such that thesensing and interface portions are on opposite sides of the socket.

The method may comprise the step of providing a spring structure in thesocket between the sensing and interface portions of the sheet.

Generally, the method according to the fourth aspect of the inventionmay comprise any step for providing a device according to any of thefirst, second, and third aspects and/or for using a device according tothe first, second, or third aspects of the invention.

LIST OF DRAWINGS

In the following, embodiments of the invention will be described by wayof example with reference to the figures in which:

FIGS. 1 and 2 illustrate a monitoring device according to the invention;

FIGS. 3 and 4 illustrate details of the socket and foil in across-sectional view;

FIG. 5 illustrates the layers in a data collector adapted for EMG signaldetection;

FIG. 6 illustrates an embodiment of the data collector suitable for ECGsignal detection;

FIGS. 7-10 illustrate details of the locking structure adapted to holdthe processor in the cavity;

FIGS. 11 and 12 illustrate a socket and details of a spring structureforming part of the socket;

FIG. 13 illustrates an exploded view of the processor; and

FIGS. 14 and 15 illustrate an embodiment where the processor is insertedsideways in a track.

Further scope of applicability of the present invention will becomeapparent from the following detailed description and specific examples.However, it should be understood that the detailed description andspecific examples, while indicating preferred embodiments of theinvention, are given by way of illustration only, since various changesand modifications within the scope of the invention will become apparentto those skilled in the art from this detailed description.

DETAILED DESCRIPTION OF DRAWINGS

FIGS. 1 and 2 illustrate a monitoring device 1 comprising a datacollector 2 and a separate processor 3 which is detachably attachable tothe data collector. In FIG. 1, the processor is attached to the datacollector, and in FIG. 2, the processor is detached from the datacollector.

The data collector comprises a flexible foil 4 made from an elasticallyor at least flexible material. On a dermal side surface 5, the foilcomprises an adhesive, e.g. a hydrocolloid adhesive for adhesion of thedata collector to a skin surface of a subject to be monitored. On anopposite, upper surface of the foil, the data collector comprises asocket 6 made from a rigid plastic material and being less flexible thanthe foil. The socket and the foil are adhesively, and preferably,non-detachably joined. The flexibility of the foil enables the foil tobe adhesively attached to the skin surface and to follow the contour ofthe body. The foil may, additionally, be lengthwise elasticallydeformable such that it can be stretched. The foil has a laminatedstructure including numerous thin layers of different materials.

The socket forms a cavity 7 for receiving the processor. The cavity hasa depth of approximately half of the height of the processor, i.e. suchthat half of the processor may be depressed into the cavity. Theprocessor includes a shoulder 8 which comes in contact with the upperedge 9 of the socket. At this point, the electrical coupling 10 of theprocessor and the electrical coupling 11 of the data collector arejoined, and electrical communication between the data collector and theprocessor is established.

To reduce impact of moisture, water, or dirt etc., the socket and/or theprocessor may include a resilient, elastically deformable, gasketlocated between the socket and the processor and which is compressedwhen the processor is inserted in the socket. The gasket could belocated on or at the shoulder 8 or on/at the upper edge 9.

The processor includes a pair of steps 12, 13 which are received inmatching windows 14, 15 in the socket. The steps provide a free spaceunder the electrical coupling of the processor, when the processor isplaced on a table etc. and thereby protects the electrical terminalsagainst contamination and wear.

FIG. 3 illustrates a cross sectional view of the data collector and FIG.4 illustrates details herein, particularly of the electrical coupling 11of the data collector. The data collector comprises a sheet 16 with apattern 17 of an electrically conductive material, herein referred to as“a first pattern”. The first pattern is printed on an outer surface ofthe sheet. A portion of the sheet, herein referred to as “a sensingportion” is integrated into the laminated structure of the foil, i.e. itforms one of the layers in the laminated structure. The sheet isfoldable, and an interface portion of the sheet is folded through anaperture or window 18 into the cavity. By this folding of the sheet, theouter surface becomes upwards, i.e. it faces towards the processor whenthe processor is received in the cavity.

Since the first pattern is applied to the outer surface of both thesensing portion and the interface portion, the folded sheet forms a veryflat and thin electrical coupling for electrically connecting theprocessor to the data collector.

FIG. 4 also illustrates an upward protrusion 19 forming a springstructure which provides a spring force in the upwards directionindicated by the arrow 20.

FIG. 5 illustrates the data collector in an exploded view, in this casein an embodiment suitable for EMG signal detection. Herein, it isclearly seen that the foil has a laminated structure including aplurality of layers, 21-27, and that the foldable sheet 25 constitutesone of the layers. The more rigid socket has numeral 28.

FIG. 5 illustrates the layers in a data collector adapted for EMG. Inthis data collector, table 1 below specifies detailed materials suitablefor each layer.

TABLE 1 Numeral Description Material 25 Foldable sheet with PET(polyester) foil with printed electrical silver/silver chlorideconductors and conductive ink electrodes, i.e. printed with the firstand second patterns of electrically conductive material. 26 Skinadhesive tape Acrylic adhesive with PET non-woven backing 24 Doublesided adhesive Acrylate adhesive tape reinforced with polyester fibers23 Skin adhesive tape Acrylic adhesive with PET non-woven backing 22Conductive Sensing Polyacrylate based Hydrogel hydrogel 27 Double sidedadhesive Acrylate adhesive tape located between reinforced withpolyester the interface portion of fibers the sheet 25 and the socket28. 29 Double sided adhesive Acrylate adhesive tape reinforced withpolyester fibers 28 Injection molded ABS (Acrylonitrile socket butadienestyrene) 21 Release liner Silicone coated PET foil

FIG. 6 illustrates an alternative embodiment of the data collector in anexploded view, in this case suitable for ECG signal detection. Again, itis clearly seen that the foil has a laminated structure including aplurality of layers, 30-37, and that the foldable sheet 34 constitutesone of the layers. The more rigid socket has numeral 38.

Table 2 below specifies detailed materials suitable for each layer inthe ECG data collector.

TABLE 2 Numeral Description Material 34 Foldable sheet with PET(polyester) foil with printed electrical silver/silver chlorideconductors and conductive ink electrodes, i.e. printed with the firstand second patterns of electrically conductive material 35 Skin adhesivetape Acrylic adhesive with PUR (Polyurethane) backing 37 Double sidedadhesive Acrylate adhesive tape reinforced with polyester fibers 39Double sided adhesive Acrylate adhesive tape reinforced with polyesterfibers 32 Skin adhesive tape Acrylic adhesive with PET non-woven backing31 Conductive Sensing Polyacrylate based Hydrogel hydrogel 30 Releaseliner Silicone coated PET foil 36 Carrier for patch Silicone coatedpaper 38 Injection molded ABS (Acrylonitrile socket butadiene styrene)33 Double sided adhesive acrylate adhesive tape reinforced withpolyester fibers

FIGS. 7-10 illustrate details of the locking structure adapted to holdthe processor in the cavity.

The locking structure comprises a number of flexible protrusions 40arranged sequentially around the upper edge 41 of the socket, i.e.mainly at the corners of the upper edge. Relative to the downwardsdirection for inserting the processor in the cavity, i.e. the directionindicated by the arrow 42, the protrusions has a beveled upper edgesurface 43 and an opposite transverse edge surface 44. Due to thebeveled upper edge surface, the depressed edge 45 of the processor 46can be pressed down in level with the protrusions, whereby theprotrusions engage the depressed edge and locks the processor to thesocket. Due to the transverse edge surface 44, the processor is fixedand can only be removed by destruction of the socket.

The socket, and particularly the protrusions are arranged and shapedrelative to the processor and particularly relative to the depressededge such that the locking structure applies a constant force on theprocessor in the downwards direction illustrated by the arrow 42, i.e.directed towards the dermal side surface thereby forcing the processorinto the cavity and downwards onto the electrical coupling formed by theinterface portion of the foldable sheet.

The socket may form a sealing edge to the processor in the cavity. Thesealing edge prevents fluid (e.g. water) from entering the cavity. Thesealing characteristics may be obtained by use of the same rigid plasticmaterials by which the socket and the processor is made, e.g. by use ofdifferent angles of the edge surface ensuring sealing. Alternatively, orin combination, a softer material, e.g. rubber or thermoplasticelastomers, may be provided on the edge of the socket or on theprocessor. The locking structure may apply a constant force on theprocessor whereby the softer material becomes deformed and sealing isobtained.

FIG. 9 illustrates an opposite end of the socket in a cross-sectionalview. In this vies, it can be seen that the socket is designed forcontrolled destruction. By breaking an end portion 47 of the socketoutwards, the locking protrusions 48 are pulled out of the depressededge 49 and the processor is released from the socket. FIG. 10illustrates that the processor can be lifted out of the socket.

FIGS. 11 and 12 illustrate a socket 6 and details of a spring structureforming part of the socket. In FIGS. 11 and 12, the sheet and the foilin which the sheet forms an integrated layer is omitted to more clearlyillustrate the spring structure. The spring structure 50 is locateddirectly adjacent the through opening forming a window 51 through whichthe interface portion of the sheet is folded. The spring structurecomprises a number of upwards protrusions best seen in FIG. 12 and beingindicated with numeral 52. The upwards protrusions are separated fromadjacent protrusions by through holes forming openings 53 (c.f. FIG. 12)in the socket. The openings are oblong and extend in a direction whichherein is referred to as “a sideways direction”.

Due to the upwards direction of the protrusions, indicated in FIG. 11 bythe arrow 54, the spring structure provides a spring force in an upwardsdirection when the protrusions are deformed downwardly upon insertingthe processor in the cavity. The spring structure forms part of thesocket 6, i.e. it is formed in one part with the socket, e.g. bypressure molding or vacuum molding etc. e.g. from a plastic materialbeing more rigid than the sheet and foil.

FIG. 13 illustrates an exploded view of the processor. The processorcomprises a top-shell 55, two PCB (printed circuit boards) 56, 57, abattery 58 and a bottom shell 59 on which the top-shell is received toform a closed capsule. Internally, the processor comprises a memoryblock 60, an antenna 61 enabling wireless communication with an externaldata recipient, a CPU (computer processing unit) 62 programmed toperform processing of data received from or transmitted to the datacollector. Additionally, the processor comprises a micro USB connectorfor connecting the processor to an external data receiver or forcharging the battery. Additionally, the processor comprises a coupling64 facing downwards and adapted for electrical connection to thecoupling in the socket of the data collector.

Where the embodiment described above is adapted for insertion of theprocessor in a downwards direction from above into the socket, FIGS. 14and 15 illustrate an embodiment where the processor is inserted sidewaysin a track formed by cooperating ledges 65 of the socket and processor.In this embodiment, the spring structure formed in the socket comprisesprotrusions separated by recesses or openings which are oblong andextend in a direction being parallel to the sideways direction indicatedby arrow 66, and the first pattern 67 printed on the interface portionof the foldable sheet forms conductors which, correspondingly, extend inparallel with the sideways direction.

Listed Embodiments

1. A monitoring device comprising a data collector and a separateprocessor, the data collector comprising a flexible foil attached to aless flexible socket, the foil forming a dermal side surface foradhesion of the data collector to a skin surface of a subject to bemonitored and the socket forming a cavity for receiving the processor,wherein the data collector further comprises a foldable sheet with afirst pattern of an electrically conductive material on an outer surfacethereof, the first pattern extending between a sensing portion of thesheet which forms a layer in the flexible foil and an interface portionof the sheet which is folded into an aperture in the socket and forms anelectrical coupling for electrically connecting the processor to thedata collector.

2. A device according to embodiment 1, where the data collector furthercomprises at least one electrode for communicating an electrical signalbetween the monitoring device and the subject, and where the firstpattern provides individual conductivity between each electrode and thecoupling.

3. A device according to embodiment 2 or 3, where the at least oneelectrode comprises a second pattern of electrically conductive materialon the outer surface of a sensing portion of the foldable sheet.

4. A device according to embodiment 3, where the second pattern and thefirst pattern are of identical electrically conductive material.

5. A device according to any of embodiments 3-4, where the socket isbetween the interface portion and the sensing portion of the sheet.

6. A device according to any of the preceding embodiments, comprising aspring structure forming part of the socket and located between theinterface portion of the sheet and the dermal side surface of the datacollector, the spring structure providing a spring force in an upwardsdirection being perpendicular to and directed away from the dermal sidesurface such that the force becomes towards the processor when theprocessor is received in the cavity.

7. A device according to any of the preceding embodiments, where theprocessor is receivable into the cavity in a downwards direction beingperpendicularly to and directed towards the dermal side surface.

8. A device according to any of the preceding embodiments, where theprocessor is receivable into the cavity in a sideways direction beingparallel to and directed towards the dermal side surface.

9. A device according to any of embodiment 6-9, where the springstructure comprises a number of upwards protrusions separated fromadjacent protrusions by a recess or opening in the socket.

10. A device according to embodiments 8 and 9, where the recesses oropenings between adjacent protrusions are oblong and extend in adirection being parallel to the sideways direction.

11. A device according to any of the preceding embodiments, where thesocket forms a locking structure adapted to hold the processor in thecavity, the locking structure being adapted to apply a constant force onthe processor in a downwards direction being perpendicularly to anddirected towards the dermal side surface thereby forcing the processorinto the cavity.

12. A device according to embodiment 11, where the locking structure isreleasable by controlled destruction at a structurally weakened portionof the socket.

13. A monitoring device comprising a data collector and a separateprocessor, the data collector comprising a flexible foil attached to aless flexible socket, the foil forming a dermal side surface foradhesion of the data collector to a skin surface of a subject to bemonitored and the socket forming a cavity for receiving the processor,wherein the processor comprises a connector for establishing a cabledconnection to an external unit, the connector being covered by thesocket, when the processor is received in the cavity.

14. A monitoring device comprising a data collector and a separateprocessor, the data collector comprising a flexible foil attached to aless flexible socket, the foil forming a dermal side surface foradhesion of the data collector to a skin surface of a subject to bemonitored and the socket forming a cavity for receiving the processor,wherein the processor and the socket have matching non symmetric shapesfacilitating the processor to be received in the cavity only in onesinge orientation of the processor relative to the socket.

15. A method of making a device according to any of embodiments 1-14,the method comprising the steps of:

-   -   providing an interface pattern of an electrically conductive        material on an outer surface of a foldable sheet;    -   providing a flexible foil which includes the foldable sheet and        which forms a dermal side surface for adhesive contact with a        skin surface;    -   providing a socket which is less flexible than the foil;    -   attaching the socket to an upper surface of the foil facing away        from the dermal side surface; and    -   folding an interface portion of the sheet through an aperture in        the socket; and    -   providing from the interface portion, a coupling for electrical        communication with a matching coupling of the processor.

1. A monitoring device comprising a data collector and a separateprocessor, the data collector comprising a flexible foil attached to aless flexible socket, the foil forming a dermal side surface foradhesion of the data collector to a skin surface of a subject to bemonitored and the socket forming a cavity for receiving the processor,wherein the data collector further comprises a foldable sheet with afirst pattern of an electrically conductive material on an outer surfacethereof, the first pattern extending between a sensing portion of thesheet which forms a layer in the flexible foil and an interface portionof the sheet which is folded into an aperture in the socket and forms anelectrical coupling for electrically connecting the processor to thedata collector.
 2. The device according to claim 1, wherein the datacollector further comprises at least one electrode for communicating anelectrical signal between the monitoring device and the subject, andwhere the first pattern provides individual conductivity between eachelectrode and the coupling.
 3. The device according to claim 2, whereinthe least one electrode comprises a second pattern of electricallyconductive material on the outer surface of a sensing portion of thefoldable sheet.
 4. The device according to claim 3, wherein pattern andthe first pattern are of identical electrically conductive material. 5.The device according to claim 3, wherein the socket is between theinterface portion and the sensing portion of the sheet.
 6. The deviceaccording to claim 1, wherein the device comprising a spring structureforming part of the socket and located between the interface portion ofthe sheet and the dermal side surface of the data collector, the springstructure providing a spring force in an upwards direction beingperpendicular to and directed away from the dermal side surface suchthat the force becomes towards the processor when the processor isreceived in the cavity.
 7. The device according to claim 1, wherein theprocessor is receivable into the cavity in a downwards direction beingperpendicularly to and directed towards the dermal side surface.
 8. Thedevice according to claim 1, wherein the processor is receivable intothe cavity in a sideways direction being parallel to and directedtowards the dermal side surface.
 9. The device according to claim 6,wherein the spring structure comprises a number of upwards protrusionsseparated from adjacent protrusions by a recess or opening in thesocket.
 10. The device according to claim 8, wherein the recesses oropenings between adjacent protrusions are oblong and extend in adirection being parallel to the sideways direction.
 11. The deviceaccording to claim 1, wherein the socket forms a locking structureadapted to hold the processor in the cavity, the locking structure beingadapted to apply a constant force on the processor in a downwardsdirection being perpendicularly to and directed towards the dermal sidesurface thereby forcing the processor into the cavity.
 12. The deviceaccording to claim 11, wherein the locking structure is releasable bycontrolled destruction at a structurally weakened portion of the socket.13. The monitoring device according to claim 1, wherein the processorcomprises a connector for establishing a cabled connection to anexternal unit, the connector being covered by the socket, when theprocessor is received in the cavity.
 14. The monitoring device accordingto claim 1, wherein the processor and the socket have matching nonsymmetric shapes facilitating the processor to be received in the cavityonly in one singe orientation of the processor relative to the socket.15. A method of making a device according to claim 1, wherein the methodcomprising the steps of: providing an interface pattern of anelectrically conductive material on an outer surface of a foldablesheet; providing a flexible foil which includes the foldable sheet andwhich forms a dermal side surface for adhesive contact with a skinsurface; providing a socket which is less flexible than the foil;attaching the socket to an upper surface of the foil facing away fromthe dermal side surface; and folding an interface portion of the sheetthrough an aperture in the socket; and providing from the interfaceportion, a coupling for electrical communication with a matchingcoupling of the processor.